TY - JOUR
T1 - Long-term outcomes of treat-and-extend ranibizumab with and without navigated laser for diabetic macular oedema
T2 - TREX-DME 3-year results
AU - Payne, John F.
AU - Wykoff, Charles C.
AU - Clark, W. Lloyd
AU - Bruce, Beau B.
AU - Boyer, David S.
AU - Brown, David M.
N1 - Funding Information:
Funding Research grant from Genentech (ML28724).
Funding Information:
Competing interests JP: Received research grant funding for TREX-DME from Genentech. Has also received research grant funding from Genentech, Regeneron and the Diabetic Retinopathy Clinical Research Network. CCW: Received personal fees from Acucela, Aerpio, Alimera, Allegro, Allergan, Apellis, Bayer, Chengdu Kanghong, Clearside Biomedical, DORC, Eyepoint, Genentech/Roche, Iveric Bio, Kodiak, Novartis, ONL Therapeutics, Outlook Therapeutics, Oxurion, PolyPhotonics, Recens Medical, Regeneron, Regenxbio, Santen and Takeda. Received research grant funding from Adverum, Aerie Pharmaceuticals, Aerpio, Allergan, Apellis, Chengdu Kanghong, Clearside Biomedical, Gemini Therapeutics, Genentech/Roche, Graybug Vision, IONIS Pharmaceuticals, Iveric Bio, Kodiak, Neurotech, Novartis, Ophthea, Outlook Therapeutics, Recens Medical, Regeneron, Regenxbio, Samsung, Santen and Xbrane Biopharma. WLC: Received personal fees from Regeneron, Genentech, Diabetic Retinopathy Clinical Research Network, Thrombogenics and Ophthea. BB: Received personal fees from Genentech, Emory University, Bayer, Medimmune and individual litigants. DSB: Received personal fees from Alcon, Allegro, Allergan, Bayer, Chengdu Kanghong and Regeneron. DB: Received personal fees from Novartis, Regeneron, Bayer, Genentech/Roche, Adverum, Kodiak, Senju, Chengdu Kanghong, Boehringer Ingelheim, Allegro, Apellis, Gemini, Regenxbio, Stealth, Santen, Heidelberg, Optos, Navilas, Ocular Therapeutics, iRenix and Lineage Cell. Received research grant funding from Novartis, Regeneron, Bayer, Genentech/Roche, Adverum, Kodiak, Senju, Chengdu Kanghong, Boehringer Ingelheim, Allegro, Apellis, Gemini, Regenxbio, Stealth, Santen, Heidelberg, Optos, Navilas, NEI, NGM, Ionis, Outlook Therapeutics, Xbrane Biopharma and Graybug Vision.
Publisher Copyright:
©
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/2/1
Y1 - 2021/2/1
N2 - Background/aims To evaluate the long-term effects of treat-and-extend dosing of ranibizumab with and without navigated focal laser for diabetic macular oedema (DME). Methods This is a multicentre, randomised clinical trial where 150 eyes were randomised into three cohorts; Monthly (n=30), TReat and EXtend without macular laser photocoagulation (TREX; n=60), and treat and extend with angiography-GuIded macular LAser photocoagulation (GILA; n=60). During the first 2 years, eyes either received ranibizumab 0.3 mg every 4 weeks or underwent treat-and-extend ranibizumab with or without angiography-guided laser therapy. In the third year, all eyes were treated as needed with ranibizumab for >5 letters vision loss or if the central retinal thickness (CRT) was >325 μm, and all eyes were eligible to receive focal laser. Results 109 eyes (73%) completed the 3-year end-point. At week 156, mean best-corrected visual acuity (BCVA) and CRT improved by 6.9, 9.7, 9.5 letters (p=0.60) and 129, 138, 165 μm (p=0.39), in the Monthly, TREX and GILA cohorts, respectively. These improvements were reached prior to week 104 and no significant changes occurred from week 104 to week 156 (BCVA: p=0.34; CRT: p=0.36). The mean number of injections in the third year was 3.0, 3.1, and 2.4 in the Monthly, TREX and GILA cohorts, respectively (p=0.56). 86 eyes (79%) required at least one ranibizumab injection in the third year. Conclusion The improvements achieved after 2 years of treat-and-extend ranibizumab for DME were maintained in the third year with a mean of 3 intravitreal injections. Trial registration number FDA IND 119146, NCT01934556.
AB - Background/aims To evaluate the long-term effects of treat-and-extend dosing of ranibizumab with and without navigated focal laser for diabetic macular oedema (DME). Methods This is a multicentre, randomised clinical trial where 150 eyes were randomised into three cohorts; Monthly (n=30), TReat and EXtend without macular laser photocoagulation (TREX; n=60), and treat and extend with angiography-GuIded macular LAser photocoagulation (GILA; n=60). During the first 2 years, eyes either received ranibizumab 0.3 mg every 4 weeks or underwent treat-and-extend ranibizumab with or without angiography-guided laser therapy. In the third year, all eyes were treated as needed with ranibizumab for >5 letters vision loss or if the central retinal thickness (CRT) was >325 μm, and all eyes were eligible to receive focal laser. Results 109 eyes (73%) completed the 3-year end-point. At week 156, mean best-corrected visual acuity (BCVA) and CRT improved by 6.9, 9.7, 9.5 letters (p=0.60) and 129, 138, 165 μm (p=0.39), in the Monthly, TREX and GILA cohorts, respectively. These improvements were reached prior to week 104 and no significant changes occurred from week 104 to week 156 (BCVA: p=0.34; CRT: p=0.36). The mean number of injections in the third year was 3.0, 3.1, and 2.4 in the Monthly, TREX and GILA cohorts, respectively (p=0.56). 86 eyes (79%) required at least one ranibizumab injection in the third year. Conclusion The improvements achieved after 2 years of treat-and-extend ranibizumab for DME were maintained in the third year with a mean of 3 intravitreal injections. Trial registration number FDA IND 119146, NCT01934556.
KW - retina
KW - treatment lasers
KW - treatment medical
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U2 - 10.1136/bjophthalmol-2020-316176
DO - 10.1136/bjophthalmol-2020-316176
M3 - Article
C2 - 32303499
AN - SCOPUS:85083670795
SN - 0007-1161
VL - 105
SP - 253
EP - 257
JO - British Journal of Ophthalmology
JF - British Journal of Ophthalmology
IS - 2
ER -